Senior Quality Affairs Officer

1100 Mylan Pharmaceuticals Inc.; Amstelveen; Hybrid; EUR 90,000 - 130,000; Full time

Benefits offered by this job

Hybrid work model

Home working budget

35 vacation days

Pension plan

Health and Wellness programs

Healthcare insurance allowance

Job summary

Mylan B.V. Viatris, Netherlands, seeks a Senior Quality Affairs Officer to ensure QP/RP responsibilities and regulatory compliance within EU and local Dutch guidelines. The role emphasizes collaboration with multiple stakeholders, audits, and strong GMP/GDP oversight.

Reporting to the Head of Quality Affairs, the successful candidate will lead quality governance, maintain regulatory alignment, and drive continuous improvement in a high-performing, inclusive environment.

Qualifications

• Life-science graduate or pharmaceutical qualification, preferably as (industrial) pharmacist.
• At least 5 years Pharmaceutical Affairs experience covering all aspects of GMP/GDP.
• Dutch native language and excellent in English (both in writing and speaking).
• Thorough knowledge of Dutch Medicines Act and EU/local GMP/GDP legislation and guidance.
• Collaborative, team-oriented with excellent people skills and the ability to communicate with multiple stakeholders.

Responsibilities

• Undertake the role of QP and RP in line with European and Dutch requirements for pharmaceutical manufacturers/importers and wholesalers.
• Manage local Technical Agreements; supplier qualification; manage PMSIs and incidents; CAPAs, Changes, Complaints, Self-inspections, Recalls, PQRs.
• Review GMP/GDP documentation and advise with respect to regulations.
• Ensure procedures (SOPs/WIs) are aligned with EU and local legislation and internal policies.
• Act as (co-)host during internal corporate or external audits/inspections; be point of contact for Competent Authorities.

Skills

GMP/GDP knowledge

QA experience

Stakeholder communication

Dutch language proficiency

English language proficiency

Education

Life-science graduate or pharmaceutical qualification

Industrial pharmacist

Job description

Mylan B.V. Viatris

Mylan B.V. Viatris is a global healthcare company uniquely positioned to bridge the traditional divide between generics and brands, combining the best of both to more holistically address healthcare needs globally. With a mission to empower people worldwide to live healthier at every stage of life, we provide access at scale, currently supplying high-quality medicines to approximately 1 billion patients around the world annually and touching all of life's moments, from birth to the end of life, acute conditions to chronic diseases. We have been included on number of award lists that demonstrate the impact we are making. Every day, we rise to the challenge to make a difference and here’s how the Senior Quality Affairs Officer role will make an impact:

Key responsibilities for this role include:

Undertake the role of QP and RP in line with the European and Dutch legal requirements for pharmaceutical manufacturers/importers and wholesalers Manage (local) Technical Agreements, Supplier qualification Management of PMSIs and incidents, CAPAs, Changes, Complaints, Self-inspections, Recalls, PQRs Review of GMP/ GDP documentation and advice with respect to regulations Ensure procedures (SOPs/WIs) are in line with EU, international legislation and internal policies and procedures. Act as (co-)host during internal corporate or external (authorities) audits/inspections Act as point of contact for the Competent Authorities on specific issues

The minimum qualifications for this role are:

Life-science graduate or pharmaceutical qualification, preferably as (industrial) pharmacist At least 5 years Pharmaceutical Affairs experience covering all aspects of GMP/GDP. Dutch Native language and excellent in English (both in writing and speaking) A thorough knowledge and understanding of Dutch Medicines Act and EU – and local GMP/GDP legislation and associated guidance and other applicable regulations Highly motivated individual who has the desire to succeed and can work under pressure Is able to prioritize and keep an overview with complex situations/process, is creative in finding solutions and achieving win-win situations Ability to easily change between the different decision criteria and processes, covered by and belonging to the different key responsibilities in this role Reporting to the Head of Quality Affairs , the ideal candidate needs to be an enthusiastic, well-rounded and motivated team player with excellent people skills. You will have a collaborative approach to work and the ability to communicate effectively with multiple stakeholders, and able to work autonomously and drive own work outcomes.

At Viatris Netherlands, we offer an inclusive, engaging, and high-performing environment where you can use your experience, perspective and skills to help make an impact - come and join us! We reward and acknowledge your contributions and offer the following:

• Competitive compensation package inclusive of annual discretionary bonus
• Focus on career progression with growth and development opportunities
• Hybrid work model and home working budget
• Emphasis on Health and Wellness programs
• 35 vacation days
• Contribution free pension plan
• Contribution free disability insurance and contribution free accident insurance
• Contribution free life insurance
• Healthcare insurance allowance
• Internet allowance
• Paid additional birth leave for partner
• Leisure discount program
• Fun social events, great barista coffee and a friendly and supportive environment

At Viatris, we offer competitive salaries, benefits and an inclusive environment where you can use your experiences, perspectives and skills to help make an impact on the lives of others. At Viatris, we offer competitive salaries, benefits and an inclusive environment where you can use your experiences, perspectives and skills to help make an impact on the lives of others. Viatris is an Equal Opportunity Employer. Viatris is a global healthcare company formed in 2020 through the combination of Mylan and Upjohn, a legacy division of Pfizer. By integrating the strengths of these two companies, including our global workforce, we aim to deliver increased access to affordable, quality medicines for patients worldwide, regardless of geography or circumstance. We believe in healthcare as it should be – empowering people worldwide to live healthier at every stage of life. Because of our unwavering belief that better access leads to better health, we leverage our best-in-class manufacturing and scientific expertise and proven commercial capabilities to bring quality medicines to patients when and where they need them.